Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer

Methods. We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score

Inclusion criteria

• Age > 18 years,
• Primary or recurrent bladder tumor with endoscopic papillary aspect,
• One or two bladder tumors,
• Cytology before RTUV showing no high-grade cells,
• Patients without tutorship or subordination (ou curatorship),
• Patients under the general social security system or qualifying through a third party,
• Informed consent signed by the patient after clear and fair information.

Exclusion criteria

• Age < 18 years,
• Allergy to mitomycin C,
• Traumatic stenting,
• Upper tract urothelial cancer,
• Urethral invasion,
• History of muscle invasive bladder cancer,
• Extensive tumor (3 cm or more),
• Any contraindication to RTUV,
• Simultaneous participation in another clinical research study,
• Patients not insured by the social security or not qualifying through a third party,
• Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,
• Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).